MeiraGTx — Third Quarter 2026 Earnings Summary

MeiraGTx reported a net loss of $51.3 million for the third quarter of 2026, driven by increased research and development expenses and a loss on its equity method investee, while cash and cash equivalents rose to $184.7 million. The company plans to submit a Marketing Authorisation Application for its lead candidate, botaretigene sparoparvovec, to the European Medicines Agency in December 2026, followed by a Biologics License Application to the FDA in early 2027. Operational milestones include the completion of enrollment for the pivotal Phase 2 AQUAx2 study for radiation-induced xerostomia, with data expected in mid-2027, and the initiation of a Phase 3 study for AAV-GAD in Parkinson's disease in the first quarter of 2027. Additionally, MeiraGTx strengthened its leadership team with new appointments to the executive and board levels and highlighted upcoming presentations on its AAV-BDNF program for genetic obesity.